Meetings with FDA Sample Clauses

Meetings with FDA. Without limiting the timing and conditions for the transfer of the U.S. BLA as set forth in Section 3.3 (Transfers in Connection with the U.S. BLA Transfer), prior to the U.S. BLA Transfer Date, upon Kiniksa’s reasonable request, Regeneron will request meetings with the FDA to discuss and seek guidance regarding the U.S. BLA in its current form and all information and data proposed by Kiniksa to be included with its supplemental BLA in the Kiniksa Field. Regeneron will use reasonable efforts to ensure that Regeneron personnel with relevant experience, including with respect to CMC and other Manufacturing activities related to the Product, attend such meeting with the FDA, along with Kiniksa or its designees. Regeneron’s Fully-Burdened Costs for providing services pursuant to this Section 3.2.2 (Meeting with FDA) shall be considered Other Shared Expenses.
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Meetings with FDA. AstraZeneca shall promptly provide Nektar with prior written or email notice of all meetings, conference calls, outbound calls, and any other discussions, whether scheduled or unscheduled, with the FDA regarding any Licensed Product, which notice shall be provided [***] given the projected date and time of such meeting, conference or discussion in order to give Nektar [***] to attend or otherwise participate in such meeting, conference or discussion as further described below. Subject to the ***Text Omitted and Filed Separately with the Securities and Exchange Commission. Confidential Treatment Requested Under
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Meetings with FDA. Beginning on the Transfer Date through the end of the Term, to the extent practicable, Licensee shall provide [***] with prior written or email notice of all meetings, conferences and discussions that are scheduled with the FDA regarding any Licensed Product [***] after Licensee or its Affiliate first receives notice of the scheduling of such meeting, conference or discussion (or within such shorter period as may be practicable and necessary in order to give AstraZeneca and Nektar a [***] to attend such meetings, conferences and discussions). For clarity, after the Transfer Date, Licensee shall not have any obligation to give Nektar or AstraZeneca the opportunity to attend meetings, conferences and discussions with the FDA that are [***], but shall use reasonable efforts to give Nektar and AstraZeneca notice as soon as practicable (whether prior to or after such meetings, conferences or discussions) of such meetings, conferences and discussions, if material. Subject to the confidentiality provisions set forth in this Agreement in Article 12, and to the extent permitted by the FDA and Applicable Laws, after the Transfer Date, Nektar and AstraZeneca shall each be entitled to have [***]. The number of representatives and the identities of such representatives to be present at any such meeting, conference or discussion shall be determined by Licensee in its good faith judgment, based solely upon considerations relating to conducting an effective interaction with the FDA. After the Transfer Date, Licensee shall not be required to account for the schedules of the Nektar or AstraZeneca representatives in scheduling such meetings, conferences or discussions except to the extent that Licensee is requiring the attendance of certain Nektar or AstraZeneca representatives, in which case Licensee shall conduct such scheduling reasonably and in good faith. AstraZeneca acknowledges that Licensee shall be the lead party and ultimately responsible for the direction of any and all regulatory interactions in the Licensed Territory except for the period prior to the Transfer Date. Licensee shall promptly forward to AstraZeneca and Nektar copies of all meeting minutes and summaries of all such meetings, conferences and discussions with any Health Authority.
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Meetings with FDA. To the extent practicable, AstraZeneca shall [***] with prior written or email notice of all meetings, conferences and discussions that are scheduled with the FDA regarding any Licensed Product [***] after AstraZeneca or its Affiliate first receives notice of the scheduling of such meeting, conference or discussion (or within such shorter period as may be practicable and necessary in order to give Nektar a [***] to attend such meetings, conferences and discussions). For clarity, AstraZeneca shall not have any obligation to give Nektar the opportunity to attend meetings, conferences and discussions with the FDA that are [***], but shall use reasonable efforts to give Nektar notice as soon as practicable (whether prior to or after such meetings, conferences or discussions) of such meetings, conferences and discussions, if material. Subject to the confidentiality provisions set forth under Article 11, and to the extent permitted by the FDA, Nektar shall be entitled to have [***]. The number of representatives and the identities of such representatives to be present at any such meeting, conference or discussion shall be determined by AstraZeneca in its good faith judgment, based solely upon considerations relating to conducting an effective interaction with the FDA. AstraZeneca shall not be required to account for the schedules of the Nektar representatives in scheduling such meetings, conferences or discussions except to the extent that AstraZeneca is requiring the attendance of certain Nektar representatives, in which case AstraZeneca shall conduct such scheduling reasonably and in good faith. AstraZeneca shall promptly forward to Nektar copies of all meeting minutes and summaries of all such meetings, conferences and discussions with the FDA.
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Related to Meetings with FDA

  • Annual Meetings with Lenders Within 120 days after the close of each fiscal year of Holdings, Holdings and Borrower shall, at the request of the Administrative Agent or Required Lenders, hold a meeting (at a mutually agreeable location and time) with all Lenders who choose to attend such meeting at which meeting shall be reviewed the financial results of the previous fiscal year and the financial condition of the Companies and the budgets presented for the current fiscal year of the Companies; and

  • Meetings and Minutes The JGC shall meet [***] or as otherwise agreed to by the Parties, with the location of in-person meetings alternating between a location designated by Morphic and a location designated by AbbVie, with AbbVie designating the place of the first meeting. The chairperson of the JGC shall be responsible for calling meetings of the JGC on no less than [***] notice unless exigent circumstances require shorter notice. Each Party shall make all proposals for agenda items at least [***] in advance of the applicable meeting and shall provide all appropriate information with respect to such proposed items at least [***] in advance of the applicable meeting; provided, that under exigent circumstances requiring input by the JGC, a Party may provide its agenda items to the other Party within a shorter period of time in advance of the meeting or may propose that there not be a specific agenda for a particular meeting, so long as the other Party consents to such later addition of such agenda items or the absence of a specific agenda for such meeting (which consent shall not be unreasonably conditioned, withheld or delayed). The chairperson of the JGC shall prepare and circulate for review and approval of the Parties minutes of each meeting within [***] after the meeting. The CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF PUBLICLY DISCLOSED. Parties shall agree on the minutes of each meeting promptly, but in no event later than the next meeting of the JGC, and such approved minutes shall be signed by each Alliance Manager.

  • Meetings by Telephone Members may participate in and hold such meeting by means of conference telephone, video conference or similar communications equipment by means of which all persons participating in the meeting can hear each other. Participation in such a meeting shall constitute presence in person at such meeting, except where a Member participates in the meeting for the express purpose of objecting to the transaction of any business on the ground that the meeting is not lawfully called or convened.

  • Regulatory Meetings The Regulatory Lead Party shall provide the other Party with notice of all meetings, conferences, and discussions (including FDA advisory committee meetings and any other meeting of experts convened by the FDA concerning any topic relevant to a Product, as well as Product labeling and post-Regulatory Approval Product labeling discussions with the FDA) scheduled with the FDA concerning any pending Drug Approval Application or any material regulatory matters relating to a Product within [****]* after the Regulatory Lead Party receives notice of the scheduling of such meeting, conference, or discussion (or within such shorter period as may be necessary in order to give the other Party a reasonable opportunity to participate in such meetings, conferences and discussions). The other Party shall be entitled to be present at, and to participate in, all such meetings, conferences or discussions. PDL’s and BMS’ respective members of the JDC shall use reasonable efforts to agree in advance on the scheduling of such meetings and on the objectives to be accomplished at such meetings, conferences, and discussions and the agenda for the meetings, conferences, and discussions with the FDA. The Regulatory Lead Party shall also include the other Party in any unscheduled, ad-hoc meetings, conferences and discussions with the FDA concerning any pending IND, Drug Approval Application or any material regulatory matters relating to a Product. * Certain information on this page has been omitted and filed separately with the SEC. Confidential treatment has been requested with respect to the omitted portions.

  • Meetings Meetings of the Trustees shall be held from time to time upon the call of the Chairman, if any, or the President or any two Trustees. Regular meetings of the Trustees may be held without call or notice at a time and place fixed by the By-Laws or by resolution of the Trustees. Notice of any other meeting shall be given by the Secretary and shall be delivered to the Trustees orally not less than 24 hours, or in writing not less than 72 hours, before the meeting, but may be waived in writing by any Trustee either before or after such meeting. The attendance of a Trustee at a meeting shall constitute a waiver of notice of such meeting except where a Trustee attends a meeting for the express purpose of objecting to the transaction of any business on the ground that the meeting has not been properly called or convened. Any time there is more than one Trustee, a quorum for all meetings of the Trustees shall be one-third, but not less than two, of the Trustees. Unless provided otherwise in this Declaration and except as required under the 1940 Act, any action of the Trustees may be taken at a meeting by vote of a majority of the Trustees present (a quorum being present) or without a meeting by written consent of a majority of the Trustees. Any committee of the Trustees, including an executive committee, if any, may act with or without a meeting. A quorum for all meetings of any such committee shall be one-third, but not less than two, of the members thereof. Unless provided otherwise in this Declaration, any action of any such committee may be taken at a meeting by vote of a majority of the members present (a quorum being present) or without a meeting by written consent of all of the members. With respect to actions of the Trustees and any committee of the Trustees, Trustees who are Interested Persons in any action to be taken may be counted for quorum purposes under this Section and shall be entitled to vote to the extent not prohibited by the 1940 Act. All or any one or more Trustees may participate in a meeting of the Trustees or any committee thereof by means of a conference telephone or similar communications equipment by means of which all persons participating in the meeting can hear each other; participation in a meeting pursuant to any such communications system shall constitute presence in person at such meeting.

  • JSC Meetings The JSC will meet at least [**], or more or less frequently as mutually agreed by the Parties, at such times as may be agreed to by the Parties. The JSC will determine its meeting locations, and whether to conduct a meeting in-person, by teleconference, or videoconference. Each Party is responsible for all costs and expenses incurred by it in connection with its participation in the meetings of the JSC. Each Party shall have the right to call a special meeting of the JSC at any time as necessary or desirable to address disputes or other matters within the scope of the JSC’s responsibilities by providing the other Parties with written notice to that effect. The JSC Chairs shall schedule and convene such special JSC meeting as soon as practicable following such notice. Each Party may, from time-to-time and with prior written notice to the JSC members of the other Parties, invite Project Team members and/or others of its employees, consultants or agents to attend relevant portions of a JSC meeting as necessary. The Sponsoring Party shall notify the other Parties in writing in the event that it wishes to invite a Third Party to attend a JSC meeting. Any such notice shall be provided at least [**] business days prior to the relevant JSC meeting and shall identify the relevant Third Party and briefly describe the reasons that the Sponsoring Party wishes to include the Third Party in the meeting. The attendance and participation of such Third Party shall be subject to the prior written consent of the Parties receiving such notice (such consent not to be unreasonably withheld). Any such consent granted by a Party shall be conditioned upon the consultant or contractor being bound by a written confidentiality and non-use agreement that is reasonably acceptable to the consenting Party. In the event the Sponsoring Party requires the attendance of such Third Party at subsequent JSC meetings, approval shall not be required for any Third Party who was previously approved by the other Parties and remains bound by an appropriate written confidentiality and non-use agreement at the time of the Project Team meeting, provided that the Sponsoring Party gives the other Parties prior notice of such attendance and the other Parties do not revoke their consent. The Parties’ respective JSC Chairs (as defined below) shall be responsible for ensuring compliance with the foregoing.

  • Meetings of Managers Meetings of the Managers may be held when called by any Managers or Manager. The Manager or Managers calling any meeting shall cause notice to be given of such meeting, including therein the time, date and place of such meeting, to each Manager at least two Business Days before such meeting. The business to be transacted at, or the purpose of, any meeting of the Managers shall be specified in the notice or waiver of notice of any such meeting. If fewer than all of the Managers are present in person, by telephone or by proxy, business transacted at any such meeting shall be confined to the business or purposes specifically stated in the notice or waiver of notice of such meeting.

  • Periodic Meetings As reasonably required by Owner, Manager and other personnel engaged or involved in the management and operation of the Properties shall meet to discuss the historical results of operations and to consider deviations from budget.

  • Conference Telephone Meetings Directors or members of any committee of the Board may participate in a meeting of the Board or such committee by means of conference telephone or similar communications equipment by means of which all persons participating in the meeting can hear each other, and such participation in a meeting shall constitute presence in person at such meeting.

  • Member Meetings (a) There shall be no meetings of the Members unless called by the Board or as otherwise specifically required by the Delaware Act. No Members or group of Members, acting in its or their capacity as Members, shall have the right to call a meeting of the Members.

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